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Mycophenolate Mofetil and Tacrolimus Versus Tacrolimus for the Treatment of Idiopathic Membranous Glomerulonephritis (MTAC)

Primary Purpose

Glomerulonephritis, Membranous

Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
tacrolimus
tacrolimus and mycophenolate mofetil
Sponsored by
Imperial College Healthcare NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glomerulonephritis, Membranous focused on measuring Glomerulonephritis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Idiopathic membranous glomerulonephritis on renal biopsy
  • Proteinuria - protein/creatinine ratio (PCR) > 100 units with hypoalbuminaemia or PCR > 300 units with normal serum albumin despite 3 months treatment with maximum tolerated doses of ace inhibitors and angiotensin 2 antagonists (or shorter if life threatening complications of nephrotic syndrome require institution of immediate immunosuppression)
  • Male or female patients aged 18 to 80 years

Exclusion Criteria:

  • Hepatitis B hepatitis C or HIV positive
  • Malignancy (all patients must have a CT chest abdomen and pelvis and other investigations if clinically indicated)
  • Untreated infection
  • Females who are pregnant, breast feeding, or at risk of pregnancy and not using a medically acceptable form of contraception
  • Any condition judged by the investigator that would cause the study to be detrimental to the patient

Sites / Locations

  • Hammersmith Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

tacrolimus

tacrolimus and mycophenolate mofetil

Arm Description

Intervention type -drug tacrolimus therapy 2mg bd adjust to obtain levels of 5-12ng/L

tacrolimus 2mgs bd (adjusted to obtain levels 5-12mg/L and mycophenolate mofetil 500mg bd adjusted to obtain levels 1.5-3mg/L

Outcomes

Primary Outcome Measures

Number of Patient Who Gained Remission From the Nephrotic Syndrome
Efficacy of mycophenolate in preventing relapse of nephrotic syndrome secondary to membranous glomerulonephritis on withdrawal of tacrolimus therapy.

Secondary Outcome Measures

Number of Patients Achieved Remission
The degree of remission of proteinuria obtained (complete or partial) The rate of decline of renal function measured by the Modification of Diet in Renal Disease equation for glomerular filtration rate.

Full Information

First Posted
February 12, 2009
Last Updated
November 21, 2019
Sponsor
Imperial College Healthcare NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT00843856
Brief Title
Mycophenolate Mofetil and Tacrolimus Versus Tacrolimus for the Treatment of Idiopathic Membranous Glomerulonephritis
Acronym
MTAC
Official Title
Mycophenolate Mofetil and Tacrolimus vs Tacrolimus Alone for the Treatment of Idiopathic Membranous Glomerulonephritis (IMG)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
March 3, 2009 (Actual)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
September 18, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College Healthcare NHS Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Study Hypothesis: When mycophenolate mofetil is added to tacrolimus in the treatment of membranous glomerulonephritis it is likely to improve the initial response to treatment and reduce the risk of relapse on stopping therapy.
Detailed Description
Membranous nephropathy is a common cause of nephrotic syndrome in adults. It is difficult to treat and if persistent leads to end stage renal failure in a significant number of patients. It is currently treated in this institution with tacrolimus monotherapy. This is effective in the majority of patients in reducing proteinuria but the remissions are often partial and patients tend to relapse when the tacrolimus treatment is stopped. We propose to use mycophenolate mofetil in combination with tacrolimus with the aim of obtaining a more complete initial response to treatment, a decreased rate of relapse on withdrawal of therapy and less progression of renal failure. This will be a randomised control trial, patients will be randomised to receive treatment with tacrolimus alone (our current standard therapy)or treatment with tacrolimus and mycophenolate mofetil. Participants will receive treatment for up to 2 years and then be monitored for relapse of their nephrotic syndrome.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glomerulonephritis, Membranous
Keywords
Glomerulonephritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
tacrolimus
Arm Type
Active Comparator
Arm Description
Intervention type -drug tacrolimus therapy 2mg bd adjust to obtain levels of 5-12ng/L
Arm Title
tacrolimus and mycophenolate mofetil
Arm Type
Active Comparator
Arm Description
tacrolimus 2mgs bd (adjusted to obtain levels 5-12mg/L and mycophenolate mofetil 500mg bd adjusted to obtain levels 1.5-3mg/L
Intervention Type
Drug
Intervention Name(s)
tacrolimus
Other Intervention Name(s)
prograff
Intervention Description
tacrolimus 2mgs bd adjusted to obtain levels of 5-12ng/ml
Intervention Type
Drug
Intervention Name(s)
tacrolimus and mycophenolate mofetil
Other Intervention Name(s)
prograf, cellcept
Intervention Description
tacrolimus 2mg bd adjusted to achieve levels of 5-12ng/L mycophenolate mofetil 500mgs bd adjusted to achieve levels of 1.5-3mg/L
Primary Outcome Measure Information:
Title
Number of Patient Who Gained Remission From the Nephrotic Syndrome
Description
Efficacy of mycophenolate in preventing relapse of nephrotic syndrome secondary to membranous glomerulonephritis on withdrawal of tacrolimus therapy.
Time Frame
10-109 weeks
Secondary Outcome Measure Information:
Title
Number of Patients Achieved Remission
Description
The degree of remission of proteinuria obtained (complete or partial) The rate of decline of renal function measured by the Modification of Diet in Renal Disease equation for glomerular filtration rate.
Time Frame
6-12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Idiopathic membranous glomerulonephritis on renal biopsy Proteinuria - protein/creatinine ratio (PCR) > 100 units with hypoalbuminaemia or PCR > 300 units with normal serum albumin despite 3 months treatment with maximum tolerated doses of ace inhibitors and angiotensin 2 antagonists (or shorter if life threatening complications of nephrotic syndrome require institution of immediate immunosuppression) Male or female patients aged 18 to 80 years Exclusion Criteria: Hepatitis B hepatitis C or HIV positive Malignancy (all patients must have a CT chest abdomen and pelvis and other investigations if clinically indicated) Untreated infection Females who are pregnant, breast feeding, or at risk of pregnancy and not using a medically acceptable form of contraception Any condition judged by the investigator that would cause the study to be detrimental to the patient
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Megan Griffith, MBChB PhD
Organizational Affiliation
Imperial College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hammersmith Hospital
City
London
ZIP/Postal Code
W12 OHS
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31492152
Citation
Nikolopoulou A, Condon M, Turner-Stokes T, Cook HT, Duncan N, Galliford JW, Levy JB, Lightstone L, Pusey CD, Roufosse C, Cairns TD, Griffith ME. Mycophenolate mofetil and tacrolimus versus tacrolimus alone for the treatment of idiopathic membranous glomerulonephritis: a randomised controlled trial. BMC Nephrol. 2019 Sep 6;20(1):352. doi: 10.1186/s12882-019-1539-z.
Results Reference
result
PubMed Identifier
34778952
Citation
von Groote TC, Williams G, Au EH, Chen Y, Mathew AT, Hodson EM, Tunnicliffe DJ. Immunosuppressive treatment for primary membranous nephropathy in adults with nephrotic syndrome. Cochrane Database Syst Rev. 2021 Nov 15;11(11):CD004293. doi: 10.1002/14651858.CD004293.pub4.
Results Reference
derived

Learn more about this trial

Mycophenolate Mofetil and Tacrolimus Versus Tacrolimus for the Treatment of Idiopathic Membranous Glomerulonephritis

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